Effect of Non-surgical Periodontal Treatment on Renal Function and C-reactive Protein Levels in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- effect of periodontal treatment on levels of systemic inflammatory markers
研究概览
简要总结
The presence of periodontitis has been hypothesized as a risk factor for several systemic outcomes, including chronic kidney disease (CKD). Therefore, the aim of this study is to evaluate the impact of non-surgical periodontal treatment on CRP levels and quality of life of patients with chronic kidney disease undergoing hemodialysis (HD) in Santa Maria-RS.
详细描述
C-reactive protein (CRP) has been identified as a possible mediator of the association between periodontitis and various systemic diseases. The presence of periodontitis has been hypothesized as a risk factor for several systemic outcomes, including chronic kidney disease (CKD). Therefore, the aim of this study is to evaluate the impact of non-surgical periodontal treatment on CRP levels and quality of life of patients with chronic kidney disease undergoing hemodialysis (HD) in Santa Maria-RS. A total of 88 patients with severe periodontitis who are on HD therapy will be included in this study. At baseline, periodontal, radiographic, blood test, and quality-of-life questionnaire will be assessed for all patients, after which severe periodontitis will be defined according to the American Association of Periodontology and European Federation of Periodontology. The 88 patients with periodontal disease will be randomized and divided into two groups. One group will receive full mouth non-surgical periodontal treatment (TPNC) and a late treatment group that will receive TPNC only at the end of the study. All patients will receive follow-up of periodontal parameters and blood collection for initial CRP assessment at 3 and 6 months after treatment. Outcome evaluators will be blind to the group the patient belongs to. Patients in the immediate treatment group will receive follow-up oral hygiene instructions and use 0.12% chlorhexidine mouthwash during the first week after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blind to the group to which the patient belongs, whether immediate or late.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having been diagnosed with chronic kidney disease (CKD) for at least 90 days.
- •Have at least 8 teeth in the mouth.
- •For the patient to be classified as having periodontal disease, he must have at least two nonadjacent sites with insertion loss of 3mm or more and two nonadjacent sites with probing depth of 4mm or more.
排除标准
- •Ineligible individuals were characterized by exhibiting one of the following conditions:
- •Patients diagnosed with malignant neoplasia;
- •Patients diagnosed with carriers of the HIV virus;
- •Pregnant or lactating women;
- •Patients with absence of all dental elements (total edentulous);
- •Patients undergoing orthodontic treatment;
- •Patients who have received periodontal treatment in the last 6 months.
- •Patients with active infection (other than periodontitis) who require antibiotic prophylaxis;
结局指标
主要结局
effect of periodontal treatment on levels of systemic inflammatory markers
时间窗: baseline changes by 6 months follow-up
To evaluate the impacts of periodontal treatment on the levels of systemic inflammatory markers such as C-reactive protein, albumin and transferrin saturation. The patients will be submitted to the collection of blood sample in the baseline, 3 and 6 months to obtain the clinical variables.
次要结局
- effect of periodontal treatment on overall quality of life and related to kidney disease(baseline changes by 6 months follow-up)
- effect of periodontal treatment on overall quality of life(baseline changes by 6 months follow-up)
- effect of periodontal treatment on psychological condition in patients with chronic kidney disease undergoing hemodialysis(baseline changes by 6 months follow-up)
- effect of periodontal treatment on psychological condition(baseline changes by 6 months follow-up)
- effect of periodontal treatment on oral health-related quality of life(baseline changes by 6 months follow-up)
研究者
Fabricio Batistin Zanatta
Principal advisor
Universidade Federal de Santa Maria